Refractive SurgeryNCT06982807
Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
A study testing Group 4.0-VISULYZE and traditional group in people with Refractive Surgery and Myopia; Refractive Error, run by Affiliated Hospital of Nantong University at 2 sites in China.
Trial summary
The aim of this study is to further optimize the surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) using the regression model established by the SMILE 4.0-VISULYZE system, thereby achieving satisfactory postoperative refractive outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Refractive Surgery, Myopia; Refractive Error
- What is being tested?
- Group 4.0-VISULYZE and traditional group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
- Age: 18 to 40 years old;
- Optimal preoperative corrected visual acuity ≥4.8;
- More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
- Patients who are willing to perform SMILE surgery
Who cannot join
- Patients with history of eye surgery and trauma;
- Patients with keratoconus tendency;
- systemic connective tissue diseases and autoimmune diseases;
- Patients with high blood pressure, diabetes and heart disease history;
- Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
- Patients with scar constitution.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Active, not recruiting
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
- Recruiting
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Wei Shi, 86 62806546, tdfykjc@163.com
About this study
The aim of this study is to further optimize the surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) using the regression model established by the SMILE 4.0-VISULYZE system, thereby achieving satisfactory postoperative refractive outcomes.
In this study, patients scheduled for SMILE surgery at the investigators' hospital will be divided into two groups: a conventional group, where the input parameters are adjusted based on historical experience according to the patient's refractive error, and a 4.0-VISULYZE group, where the input parameters are optimized using the SMILE 4.0-VISULYZE system.
The investigators will compare the postoperative outcomes between the two groups, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and the proportions of patients achieving postoperative visual acuity ≥0.8, ≥1.0, and ≥1.2 at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year post-surgery. Additionally, the investigators will evaluate the proportions of patients with postoperative SE within ±0.50D and ±1.0D, as well as postoperative cylindrical power within ±0.50D and ±1.0D, to assess the efficacy and safety of the SMILE 4.0-VISULYZE system in treating refractive errors.
- Conditions
- Refractive Surgery, Myopia; Refractive Error
- Being tested
- Group 4.0-VISULYZE, traditional group
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 4.0-VISULYZEProcedure or surgery
The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
traditional groupProcedure or surgery
The traditional group had their infusion rates based on past experience.
| Study group | Role | What they receive |
|---|---|---|
| Group 4.0-VISULYZE group | Experimental | The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE Receives: Procedure: Group 4.0-VISULYZE |
| traditional group | Active comparator | The traditional group had their infusion rates based on past experience. Receives: Procedure: traditional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent
Use autorefractor-keratometer and phoroptor to measure degree of myopia and astigmatism，then derive the spherical equivalent.
Measured: preoperative, postoperative 10 days, 1, 3, 6, 12 months
Secondary outcomes (2)
uncorrected distance visual acuity
Use a standardized visual acuity chart (e.g., Snellen or LogMAR chart)
Measured: preoperative, postoperative 10 days, 1, 3, 6, 12 months
corrected distance visualacuity
Use autorefractor-keratometer and phoroptor
Measured: preoperative, postoperative 10 days, 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive SurgeryStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982807
- Sponsor's protocol ID
- 2024-K270
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao L, Gao N, Liu E, Cheng X, Li J, Ji H, Yu Y. Comparative Validation of a VISULYZE-Based Nomogram for Predicting Visual Outcomes and Higher-Order Aberrations After SMILE in High Myopia. J Ophthalmol. 2026 Jun 18;2026:1918446. doi: 10.1155/joph/1918446. eCollection 2026.
PubMed 42328095
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
- ClinicalTrials.gov ID
- NCT06982807
- Acronym / sponsor ID
- 2024-K270
- Conditions
- Refractive Surgery, Myopia; Refractive Error
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to further optimize the surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) using the regression model established by the SMILE 4.0-VISULYZE system, thereby achieving satisfactory postoperative refractive outcomes.
In this study, patients scheduled for SMILE surgery at the investigators' hospital will be divided into two groups: a conventional group, where the input parameters are adjusted based on historical experience according to the patient's refractive error, and a 4.0-VISULYZE group, where the input parameters are optimized using the SMILE 4.0-VISULYZE system.
The investigators will compare the postoperative outcomes between the two groups, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and the proportions of patients achieving postoperative visual acuity ≥0.8, ≥1.0, and ≥1.2 at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year post-surgery. Additionally, the investigators will evaluate the proportions of patients with postoperative SE within ±0.50D and ±1.0D, as well as postoperative cylindrical power within ±0.50D and ±1.0D, to assess the efficacy and safety of the SMILE 4.0-VISULYZE system in treating refractive errors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 4.0-VISULYZE group | Experimental | Procedure: Group 4.0-VISULYZEThe 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE |
| traditional group | Active comparator | Procedure: traditional groupThe traditional group had their infusion rates based on past experience. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
- Age: 18 to 40 years old;
- Optimal preoperative corrected visual acuity ≥4.8;
- More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
- Patients who are willing to perform SMILE surgery
Key exclusion criteria (6 listed)
- Patients with history of eye surgery and trauma;
- Patients with keratoconus tendency;
- systemic connective tissue diseases and autoimmune diseases;
- Patients with high blood pressure, diabetes and heart disease history;
- Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 4.0-VISULYZEThe 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE | Procedure or surgery | Group 4.0-VISULYZE group |
| traditional groupThe traditional group had their infusion rates based on past experience. | Procedure or surgery | traditional group |
Primary outcome
spherical equivalent
Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months
Use autorefractor-keratometer and phoroptor to measure degree of myopia and astigmatism，then derive the spherical equivalent.
2 secondary outcomes
uncorrected distance visual acuity
Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months
corrected distance visualacuity
Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Derived from this study: PubMed 42328095Zhao L, Gao N, Liu E, Cheng X, Li J, Ji H, Yu Y. Comparative Validation of a VISULYZE-Based Nomogram for Predicting Visual Outcomes and Higher-Order Aberrations After SMILE in High Myopia. J Ophthalmol. 2026 Jun 18;2026:1918446. doi: 10.1155/joph/1918446. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 4.0-VISULYZE and traditional group in people with Refractive Surgery and Myopia; Refractive Error, run by Affiliated Hospital of Nantong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Yu, professor (86 15996621616, yuying.2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spherical equivalent (time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06982807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.